Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
✓ APPROVED
Foundayo (orforglipron) was approved by the FDA on April 1, 2026 to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition, in combination with a reduced-calorie diet and increased physical activity, the 11th novel drug approval of 2026 on the FDA's Novel Drug Approvals list.
Eli Lilly and Company, Foundayo (orforglipron) · Obesity.
Run-up into the decision (T-120 → T+5)
Daily close, T-120 (10/15/25) through T+5. Run-up high $1109.94 on 12/2/25, low $799.57 on 10/28/25 (T-120 to T-1). FDA decision 4/1/26. Historical price action, not a forecast.
Key facts
FDA decision date2026-04-01
OutcomeApproved
Drug / candidateFoundayo (orforglipron) - (ATTAIN-1)
CompanyEli Lilly and Company
120-day run-up (T-120→T-1)+8.8%
FDA record of the action: the FDA approved on April 1, 2026, per NDA 220934 ORIG-1 (FDA letter). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
Specialist biotech funds holding LLY, 13F for the quarter ended June 30, 2026
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
Questions
Was Foundayo (orforglipron) approved by the FDA?
Yes. The FDA approved the application for Foundayo (orforglipron) on April 1, 2026, per the FDA's own record. The primary source is linked on this page.
Which company is behind Foundayo (orforglipron)?
Foundayo (orforglipron) is an Eli Lilly and Company (LLY) program. The FDA decision came on April 1, 2026; the FDA's own record of the decision is linked on this page.
How did LLY stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), LLY moved +8.8%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
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